Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bosentan
Drug ID BADD_D00285
Description Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.
Indications and Usage Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).
Marketing Status Prescription
ATC Code C02KX01
DrugBank ID DB00559
KEGG ID D01227
MeSH ID D000077300
PubChem ID 104865
TTD Drug ID D0U4CE
NDC Product Code 68382-447; 68180-387; 46708-881; 65162-873; 49884-058; 66215-103; 0054-0521; 65162-874; 0591-2512; 47781-271; 65015-770; 66215-101; 68382-446; 49884-059; 53104-7703; 47335-039; 0054-0520; 82245-0104; 0591-2511; 14501-0041; 66215-232; 47335-038; 70771-1018; 66215-102; 70771-1017; 66039-870; 47781-270; 68180-386; 65015-753
Synonyms Bosentan | 4-t-Butyl-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide | Bosentan Monohydrate | Tracleer | Bosentan Anhydrous | Ro 47-0203 | Ro 47 0203 | Ro 470203 | Ro-47-0203
Chemical Information
Molecular Formula C27H29N5O6S
CAS Registry Number 147536-97-8
SMILES CC(C)(C)C1=CC=C(C=C1)S(=O)(=O)NC2=C(C(=NC(=N2)C3=NC=CC=N3)OCCO)OC4=CC=CC=C4OC
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HyperphosphatasaemiaBile salt export pumpO95342T3396911309550; 12127422; 11557132
Liver disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
Liver disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Liver injuryBile salt export pumpO95342T3396911309550; 12127422; 11557132
Lung disorderEndothelin-1P05305T2507610564099; 11230754; 12713865; 15185300
Lung disorderNitric oxide synthase, endothelialP29474T0604610564099; 11230754; 12713865; 15185300
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.0010.000447%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.000894%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.001341%Not Available
Acute respiratory distress syndrome22.01.03.0010.000408%
Acute respiratory failure22.02.06.001; 14.01.04.0040.001575%Not Available
Adenocarcinoma16.16.01.0040.000117%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.0030.023920%
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Alveolitis allergic22.01.01.002; 10.01.03.0080.000175%Not Available
Ammonia increased13.03.01.0230.000894%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Amyloidosis10.02.05.0010.000117%Not Available
Anaemia01.03.02.0010.020791%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Aneurysm24.02.01.0010.000292%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.002459%
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Ankle fracture15.08.03.005; 12.04.01.0050.002683%
Anuria20.01.03.0020.000894%Not Available
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